Palindrome RT Chronic Catheter Kit Withdrawn for Labeling Updates
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance Instructions for Use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a voluntary administrative withdrawal involving labeling and instruction improvements. No safety defect, adverse events, injuries, or illnesses are reported in the source. Per the rubric, labeling updates and documentation improvements with no identified hazard constitute 'Low' severity.
Plain-English summary
Covidien, LP is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P from worldwide distribution to implement point-of-use labeling on each device and enhance the Instructions for Use.
The affected lot numbers are: 1729700119, 1817700205, 1910600266, 2014900148, 1810400147, 1828900137, 2014900151, and 2034400131.
Healthcare providers using devices from the affected lots should contact Covidien for guidance regarding the labeling updates and instruction enhancements to ensure proper device handling and use.
The recalled product
- Product
- Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
- Manufacturer
- Covidien, LP
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 18 recalled by Covidien, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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